MDR QMS Notified Body Assessment

In this webinar session, we discussed critical aspects of MDR compliance, covering both Quality Management Systems (QMS). We also discussed the relationship between MDR and ISO 13485:2016, including references to ISO, EN, Harmonized Standards and Annex Z, which shows how ISO 13485 coverage is integrated into the MDR. We will also delve into the QMS documentation and procedure requirements specific to the MDR, including common gaps observed during audits. This session will provided key insights into how to ensure your QMS is fully aligned with the MDR requirements.

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MDR QMS Notified Body Assessment Topics Covered

Overview of MDR QMS Notified Body Assessment

During the session, Salman shared key insights from the perspective of a notified body, providing a detailed breakdown of MDR compliance requirements, particularly focusing on auditing QMS during onsite assessments. 

Key Topics Covered: 

1. Auditing QMS Under MDR: Salman explained the fundamental steps that auditors take when assessing a manufacturer’s QMS to ensure it meets MDR requirements, referencing Annex IX of the regulation. 
2. Most Common Non-Conformities: We discussed common non-conformities identified during audits, such as: 
   • Lack of documented procedures 
   • Insufficient controls over subcontracted activities 
   • Missing unannounced audit procedures 
   • Inadequate change notification processes 
3. Subcontracted Activities and Unannounced Audits: A focus was placed on the need to properly document and control subcontracted activities, as well as ensure that procedures are in place for handling unannounced audits. 
4. Change Notification Procedures: The importance of having clear and effective procedures for notifying notified bodies of significant changes was emphasized. 
5. EU Representative & Contractual Obligations: An in-depth discussion on the role of the EU representative, their contractual obligations, and the requirements for demonstrating compliance within the QMS. 
6. Post Market Surveillance and Clinical Follow-Up: We highlighted the importance of a robust post-market surveillance plan and ensuring a clinical follow-up is in place, even when not explicitly required. 

Key Takeaways: 

• Process Focus: Auditors primarily focus on the processes you have in place, not necessarily the content of your documents. Ensuring that processes are well-documented and followed is crucial. 

• Continuous Compliance: For successful MDR compliance, procedures must be maintained and followed, with emphasis on post-market surveillance, clinical follow-ups, and ensuring compliance with all relevant standards. 
• Regular Audits: Notified bodies conduct frequent and sometimes unannounced audits to assess compliance, and manufacturers must be prepared. 

We hope this webinar series has helped clarify the intricacies of MDR compliance. If you missed any sessions, don’t worry—recordings and materials are available. Be sure to follow us on LinkedIn for the latest updates, resources, and more webinars in the future!